BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MASK, HIGH CONC, ELONG, ADULT

    MDR report key: 3970600 · Received June 2, 2014

    Report

    Report Number
    3004365956-2014-00204
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS PERFORMED ON THE PICTURES PROVIDED BY THE CUSTOMER, AND IT CAN BE OBSERVED THAT THE 10170 (BREATHING BAG SMALL) IS UN-ATTACHED FROM THE GROMMET. HOWEVER THIS ISSUE HAPPENED AFTER 7 DAYS OF BEING IN USE AS IT IS DESCRIBED ON THIS CUSTOMER COMPLAINT. A DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE IT IS NOT POSSIBLE TO DETERMINE IN WHICH CONDITIONS THIS MATERIAL WAS MANUFACTURED. IT IS NOT POSSIBLE TO ESTABLISH A CORRECTIVE ACTION SINCE THE LOT NUMBER OF THE DEFECTED SAMPLE WAS NOT PROVIDED IN ORDER TO CONDUCT A PROPER INVESTIGATION. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE PICTURES AND INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATED THE SAMPLE INVOLVED ON THE INCIDENT. IF THE DEFECTIVE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE RESERVOIR BAG FELL WHILE IN USE. THE DEVICE WAS IN USE FOR SEVEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320929 HUDSON MASK, HIGH CONC, ELONG, ADULT HIGH CONCENTRATION MASK BYG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1